All liquid drug products manufactured by Davie-based PharmaTech have been recalled over a risk of potential contamination with Burkholderia cepacia (B. cepacia), the U.S. Food & Drug Administration (FDA) has announced.
Free Confidential Lawsuit Evaluation: If you or a loved one got an infection after using any of the products listed in this article, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the problem?
August 16, 2017 – After an FDA quality control inspection of PharmaTech’s plant in May found problems with its quality control processes, the company abandoned the facility, took down its website and disconnected the phone number, a spokesman for the town of Davie, Florida, said.
Products affected by the recall were distributed through Leader Brand, Major Pharmaceuticals and Rugby Laboratories, and could possibly be contaminated with B. cepacia bacteria, according to an FDA Recall Notice issued Thursday.
Testing of PharmaTech’s Diocto Liquid (oral liquid docusate) detected a strain of B. cepacia linked to recent patient infections, the notice said.
On August 3, Rugby issued a recall for Diocto Liquid and Diocto Syrup, which are stool softeners used to treat constipation. One week after the initial recall, the action was expanded to include all liquid products made by PharmaTech LLC.
The recall affects 22 medications from 3 different companies:
Leader Brand Recall
- Liquid Multivitamin Supplement for Infants and Toddlers and Liquid Vitamin D Supplement for Breastfed Infants.
Major Pharmaceuticals Recall
- Certa Vite Liquid
- Poly Vita Drops
- Poly Vita Drops With Iron\
- Ferrous Drops Iron Supplement
- D-Vita Drops
- Tri-Vita Drops
- Senna Syrup
Rugby Laboratories Recall
- C Liquid
- Diocto Liquid
- Ferrous Sulfate
- Fer Iron Liquid
- Diocto Syrup
- Aller Chlor Syrup
- Cerovite Liquid
- D3 400iu Liquid
- Poly-Vitamin Liquid
- Tri-Vitamin Liquid
- Poly Vitamin with Iron Liquid
PharmaTech’s drugs and dietary supplements intended for use in infants and children may be contaminated as well, FDA said. Affected products were distributed across the U.S. to wholesale and retail facilities, including hospitals and pharmacies.
Consumers who believe they have experienced adverse reactions from any of the products should contact their healthcare provider right away.
While B. cepacia bacteria causes little medical risk to healthy people, it can cause severe infections — including serious respiratory infections — in patients with cystic fibrosis, according to the Centers for Disease Control and Prevention (CDC).
Do I Have a B. Cepacia Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in B. cepacia lawsuits. We are handling individual litigation nationwide and currently accepting new infection cases in all 50 states.
Free Case Evaluation: Again, if you developed a B. cepacia infection, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.